Liver Research Data Manager

The post holder will be responsible for data management and full administrative service to the Liver Clinical Trials team. The post-holder will also be supporting the team's portfolio of commercial and non-commercial clinical trials.

Responsibilities will include completion of case report forms, liaising with clinical trials Sponsors, day to day office management and maintenance of clinical trials documentation, processes and database.

The post holder will work closely with the liver research nurses, clinical trial coordinators, clinical team and clinical trials sponsors and representatives.

Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.

Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.

Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsor's SOP.

Assist in carrying out audit and monitoring activities related to research. This will mean assisting both internal and external monitors of research.

To assist in adhoc tasks to support various developments, projects and events within the team.

The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.

We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.

King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.

1. Clinical Responsibilities

Responsible for accurate completion of Case Report Forms (CRFs).

Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.

Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.

Act as a resource and support to patients and their relatives, explaining practical aspects of clinical trials, assisting and supporting nursing teams.

Act as a resource for liver based research.

Work in accordance with all regulatory requirements including:

• Local Standard Operating Procedures (SOPs)
• Good Clinical Practice
• Medicines for Human Use (Clinical Trials) Regulations
• Research Governance Framework for Health and Social Care

• Human Tissue Act

• Portfolio Management and Development

Maintain the TMF/ISF with essential documents.

Help and organise initiation meetings.

Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of patient under the supervision of clinical trial coordinator.

Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsor's SOP.

Liaise with other departments and wards at the site/s, in order to promote a good working environment, integration of research within and open channels of communication.

Inform appropriate medical personnel and departments of portfolio of clinical trials.

Report adverse incidents and near misses via the Trust's online incident reporting form.

Act as a link for Liver Clinical Trials team and KHPCTO and KCH R&I Department

To organise and issue documents to visiting Sponsors and affiliates

To contribute to the writing and maintaining of SOPs that cover the areas of responsible work, as supervised by the CTC.

Assist in carrying out audit and monitoring activities related to research. This will mean assisting both internal and external monitors of research

1. Office Management

Arrange and provide administrative support for meetings, including minute taking, preparing agendas and following up actions, compiling and distributing papers, booking meeting rooms and arranging catering, providing travel directions and acting as the first point of contact for members regarding meeting arrangements and attendance. This may require travel to and attendance at meetings at different locations within KCH, and other Trusts.

Ensure the availability of office supplies, furniture and equipment and procurement of goods for the Clinical Trials team.

Act as first point of contact for callers to the Liver Clinical Trials Team, and for telephone and written enquiries.

Assist in organising patient appointments

Manage an effective system for processing patient travel claims and liaising with Finance Department

Type correspondence, memos, e-mails and other documents from audiotape, written copy, dictation or verbal instructions, and to generate own correspondence as required.

File correspondences from Sponsors, and any patient related activity.

To assist in adhoc tasks to support various developments, projects and events within the team.

Ensure that accrual data is uploaded onto the UKCRN portal/EDGE and is reported to the SELCRN co-ordinating centre as required

1. Training and Development

Attend the KHPCTO and KCH R&D Department training programmes and other relevant education and training days/programmes as appropriate.

Attend investigator/initiation meetings and conferences when required.

Maintain awareness of current advances in treatments, research and nursing practice and use this knowledge to maintain high standards of care

Disseminate research by assisting in the preparation of posters/research papers for meetings, conferences and publications. Also circulate trial information and carry our presentations locally.

Demonstrate the use of database systems and train colleagues and researchers.

1. Professional

Actively participate in personal development together with line manager. Ensure performance is appraised following the Trust appraisal and KAD procedures.

Develop a clear understanding of the service and the role. Also able to provide cover for colleagues in the area when necessary

Attend the KHPCTO and KCH R&D Department training programmes and other relevant education and training days/programmes as appropriate.

Attend investigator meetings and conferences when required.

1. General responsibilities

The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.

To observe the rules, policies, procedures and standards of King's College Hospital NHS Foundation Trust together with all relevant statutory and professional obligations.

To observe and maintain strict confidentiality of personal information relating to patients and staff.

To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.

Collect and provide information to allow for invoices to be raised for payments where appropriate

Support the Senior Clinical Trials Coordinator in the management of agreements, to include obtaining signatures, sharing documents by email and post, and tracking workload, processing all in an efficient and timely way to ensure expedience, as directed by the CTC and Research Facilitator.

Coordinate with support departments such as Radiology, histology and pathology to collect up to date treatment costs to form part of the Clinical Trials Agreement contract.